Ameda Platinum - Technical Information and Compliance; Operational and Storage Parameters; Product Dimensions and Safety Standards; Electrical and Performance Specifications

8 ENGLISH
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltageuctuations/ickeremissions Complies
IEC 61000-3-3
Electromagnetic environment – guidance
The Ameda Platinum Breast Pump uses RF energy
only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
anyinterferenceinnearbyelectronicequipment.
The Ameda Platinum Breast Pump is suitable
for use in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
The Ameda Platinum Breast Pump is intended for use in
the electromagnetic environment specified below.
The customer or the user of the Ameda Platinum Breast
Pump should assure that it is used in such an environment.
Operational Conditions: Pump
Temperature+53°F(+12°C)to+93°F(+34°C)
RelativeHumidity20%to70%
Atmospheric Pressure 0.82atm(83.1kPa)to1.05atm
(106.4kPa)
Transport and Storage Conditions: Pump
Temperature-10°F(-23°C)to+130°F(+54°C)
RelativeHumidity20%to90%
Atmospheric Pressure 0.82atm(83.1kPa)to1.05atm
(106.4kPa)
Weight: Approximately9.75lbs.(approximately4.42kg)
Dimensions: Length9.75in.(24.7cm)/Width 10.5 in.
(26.7cm)/Height8.0in.(20.3cm)
Standards:
E325189 MEDICAL EQUIPMENT
WITHRESPECTTOELECTRICSHOCK,
FIREANDMECHANICALHAZARDSONLY
INACCORDANCEWITH
IEC60601-1: 1988 + A1:1991 + A2:1995,
IEC60601-1-2,CAN/CSAC22.2No.601.1-M90
MEDICAL ELECTRICAL EQUIPMENT needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC provided in these Instructions for use.
PortableandmobileRFcommunicationsequipmentcan
affect MEDICAL ELECTRICAL EQUIPMENT.
Warning:TheuseofACCESSORIES,transducersand
cables other than those specified, with the exception of
transducers and cabled sold by the MANUFACTURER of the
Guidance and manufacturer’s declaration – electromagnetic immunity
NOTE: U t is the a.c. mains voltage prior to application of the test level.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast
transient/burstIEC
61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Powerfrequency
(50/60Hz)magnetic
field IEC 61000-4-8
IEC 60601 test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines/±1kVfor
input/outputlines
±1kVline(s)toline(s)
±2kVline(s)toearth
<5% U t(>95% dip in
U t)for0,5cycle
40% U t(60%dipin
U t)for5cycles
70% U t(30%dipin
U t)for25cycles
<5% U t(>95% dip in
U t)for5s
3A/m
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines/±1kVfor
input/outputlines
±1kVline(s)toline(s)
±2kVline(s)toearth
<5% U t(>95% dip in
U t)for0,5cycle
40% U t(60%dipin
U t)for5cycles
70% U t(30%dipin
U t)for25cycles
<5% U t(>95%dipin
U t)for5s
3A/m
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relativehumidityshouldbeatleast30%.
Mainspowerqualityshouldbethatofatypical
commercial or hospital environment.
Mainspowerqualityshouldbethatofatypical
commercial or hospital environment.
Mainspowerqualityshouldbethatofatypical
commercial or hospital environment. If the user
oftheAmedaPlatinumBreastPumprequires
continued operation during power mains
interruptions, it is recommended that the Ameda
Platinum Breast Pump be powered from an
uninterruptible power supply.
Powerfrequencymagneticeldsshouldbeat
levels characteristic of a typical location in a
typical commercial or hospital environment.
The Ameda Platinum Breast Pump is intended for use in
the electromagnetic environment specified below.
The customer or the user of the Ameda Platinum Breast
Pump should assure that it is used in such an environment.
Ameda Platinum Breast Pump as replacement parts for
internalcomponents,mayresultinincreasedEMISSIONSor
decreasedIMMUNITYoftheAmedaPlatinumBreastPump.
Warning: The Ameda Platinum Breast Pump should not
beusedadjacenttoorstackedwithotherequipment.If
adjacentorstackeduseisnecessary,theAmedaPlatinum
Breast Pump should be observed to verify normal operation
in the configuration in which it will be used.